A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

CompletadoFase 2ClinicalTrials.gov

ID: NCT03662542Tipo: INTERVENTIONALInicio: 20 de nov de 2018Fin estimado: 15 de nov de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening
Moderately to severely active UC as defined by Mayo score
History of inadequate response to or failure to tolerate conventional therapy
Has screening laboratory test results within the study protocol defined parameters
A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin) pregnancy test result at screening and a negative urine pregnancy test result at Week 0

Criterios de exclusión

Has severe extensive colitis as defined in the study protocol
Has UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon
Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening)
Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients

Intervenciones

drug

Guselkumab Dose 1

Guselkumab Dose 1 will be administered as IV infusion.

drug

Guselkumab Dose 2

Guselkumab Dose 2 will be administered as SC injection.

drug

Golimumab Dose 1

Golimumab Dose 1 will be administered as SC injection.

drug

Golimumab Dose 2

Golimumab Dose 2 will be administered as SC injection.

drug

Placebo

Placebo will be administered.

Ubicaciones

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

Expertia S.A

Caba, Argentina

Centro Médico Dra. De Salvo

Caba, Argentina

Clínica Adventista Belgrano

Ciudad de Buenos Aires, Argentina

Fundacion de Estudios Clinicos

Rosario, Argentina

Hospital de Alta Complejidad en Red 'El Cruce'

San Juan Bautista, Argentina

Sanatorio 9 de Julio

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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